Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension

Condition(s) targeted: Hypertension

Intervention: Valsartan (Drug); Enalapril (Drug); placebo matched to enalapril (Drug); placebo matched to valsartan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis Pharmaceuticals

The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.

Official title: An Extension to Study Protocol CVAL489K2302 to Evaluate the Long Term Safety, Tolerability and Efficacy of Valsartan in Children 6 to 17 Years of Age With Hypertension, Versus Enalapril Treatment for 14 Weeks, or Combined With Enalapril Versus Enalapril for 66 Weeks in Chronic Kidney Disease Patients.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Number of Patients With Adverse Events

Secondary outcome:

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26

Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26

Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20

Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Successful completion of 12 weeks of double-blind treatment in core protocol

CVAL489K2302.

- Patients participating in study CVAL489K2302 who may have discontinued prematurely

due to uncontrolled hypertension defined as MSSBP > 20%, but < 25% above the 95th percentile for age, gender, and height after visit 5, qualifies a patient for entry into this extension study. Exclusion Criteria:

- Renal artery stenosis.

- Current diagnosis of heart failure (NYHA Class II-IV).

- Second or third degree heart block without a pacemaker.

- Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.

- Clinically significant valvular heart disease.

- Patient that demonstrates clinically significant ECG abnormalities other than those

associated with left ventricular hypertrophy and AV block controlled with a pacemaker.

- Previous solid organ transplantation except renal, liver or heart transplantation.

Renal, liver or heart transplant must have occurred at least 6 months prior to enrollment. Patient must be on stable doses of immunosuppressive therapy for 3 months and deemed clinically stable by the investigator.

- Patients who experienced any adverse events considered serious and drug related in

protocol CVAL489K2302. Other protocol-defined inclusion/exclusion criteria applied to the study.

Sites in Belgium, Belgium, Belgium

Sites in France, France, France

Sites in Germany, Germany, Germany

Sites in Hungary, Hungary, Hungary

Sites in India, India, India

Sites in Italy, Italy, Italy

Sites in Poland, Poland, Poland

Sites in Turkey, Turkey, Turkey

Sites in USA, East Hanover, New Jersey 07936, United States

Starting date: June 2007
Last updated: June 30, 2011